Unique ID issued by UMIN | UMIN000004861 |
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Receipt number | R000005784 |
Scientific Title | Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment |
Date of disclosure of the study information | 2011/01/12 |
Last modified on | 2011/01/12 10:14:08 |
Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment
Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment
Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment
Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment
Japan |
Non-muscle invasive bladder cancer (pTa-1, G1-2)
Urology |
Malignancy
NO
The recurrence-preventive effects and safety of intravesical infusion therapy administered immediately after TUR-Bt of THP (within 24 hours) and additional maintenance therapy will be investigated in patients with low- and intermediate-risk non-muscle invasive bladder cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
Recurrence-free rate (survival period and rate) (investigation in all patients, by risk (low and intermediate), and time (at 1, 2, and 3 years))
Safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Pirarubicin (THP) at 30 mg will be infused into the urinary bladder for about 30 minutes within 24 hours after TUR-Bt in both groups.
Group A: The course will be observed.
Group B: THP at 30 mg will be infused into the urinary bladder once a week 9 times.
Not applicable |
Not applicable |
Male and Female
(1) Non-muscle invasive bladder cancer (pTa-1,G1-2).
(2) Patients who can periodically undergo cystoscopic diagnosis of recurrence after surgery.
(3) Curative resection of all visible tumors can be performed.
(4) Agreement form for this study should be obtained from the patient.
(1) Patients who previously underwent intravesical infusion therapy with BCG.
(2) Patients who underwent maintenance intravesical infusion therapy with anticancer drugs within 1 year.
(3) Patients with history or present disease of upper urinary tract utotherial carcinoma. (4) Patients with duplex of active other malignant disease.
(5) Function of all organs are without severe dysfunction.
(6) Inappropriate patients for this study judged by the physicians.
260
1st name | |
Middle name | |
Last name | Kazuya Mikami |
Kyoto Prefectural University of Medicine
Department of Urology
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
075-251-5595
1st name | |
Middle name | |
Last name | Kazuya Mikami |
Kyoto Prefectural University of Medicine
Department of Urology
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
075-251-5595
info@kpum-urology.jp
Department of Urology, Kyoto Prefectural University of Medicine
None
Self funding
KPUM-Oncology Study Group
NO
京都府立医科大学附属病院(京都府)、松下記念病院(大阪府)
2011 | Year | 01 | Month | 12 | Day |
Unpublished
Open public recruiting
2010 | Year | 09 | Month | 15 | Day |
2010 | Year | 10 | Month | 01 | Day |
2015 | Year | 08 | Month | 01 | Day |
2011 | Year | 01 | Month | 12 | Day |
2011 | Year | 01 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005784
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